Kornimate/medical-research-clean huggingface dataset:
a study of tecogalan sodium

Conditions: Sarcoma, Kaposi; HIV Infections

Summary: to evaluate the safety of different doses and dosing regimens of tecogalan sodium (ds-4152) and to establish the mtd at each of the different dosing schedules.

patients receive intravenous ds-4152 by infusion twice weekly for 21 days, followed by 2 weeks of rest; courses may repeat. patients undergo weekly follow-up. a punch biopsy will be obtained from patients with kaposi's sarcoma.

Eligibility criteria:
inclusion criteria patients must have: * kaposi's sarcoma plus hiv infection or metastatic solid tumor. * life expectancy of at least 12 weeks. * no symptomatic aids-defining opportunistic infection within the past 4 weeks. * recovered from toxicity of any prior anticancer therapy. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * leukemia or lymphoma. * current gastrointestinal bleeding by stool guaiac. * extensive bone metastases or significant radiographic osteoporosis in patients with solid tumors. * active heart disease such as uncontrolled angina, uncompensated congestive heart failure, or dysrhythmias requiring antiarrhythmics. * acute intercurrent infection other than genital herpes. * symptomatic or known central nervous system involvement (including brain metastases) unless stable and off therapy. concurrent medication: excluded: * other anticancer therapy. * other investigational agents. patients with the following prior conditions are excluded: * history of acute or chronic gastrointestinal bleeding or inflammatory bowel disease. * history of myocardial infarction within past 6 months. prior medication: excluded: * anticancer therapy within the past 3 weeks (6 weeks for nitrosourea or mitomycin c). * investigational agents within the past 4 weeks.

Keywords: neoplasms sarcoma, kaposi acquired immunodeficiency syndrome antineoplastic agents tecogalan
a real-world study to evaluate the clinical performance and safety of da vinci sp surgical system for single-port urological surgeries

Conditions: Urological Surgeries

Summary: study name：a real-world study to evaluate the clinical performance and safety of da vinci sp surgical system for single-port urological surgeries； study purpose：this clinical trial is a real-world study to evaluate the clinical performance and safety of da vinci sp surgical system ("sp single-port robot" for short) for single-port urological robotic surgeries in the real world, providing a real world evidence for clinical application of the product in the chinese population. study design：retrospective + prospective, real-world study investigational medical device： english name: da vinci sp surgical system model and specification: sp1098 manufacturer: intuitive surgical, inc.


Eligibility criteria:
inclusion criteria: subjects should meet all the following criteria: 1. subjects who have received or plan to receive rp, pn, rn, radical resection of the renal pelvic carcinoma (one position), pyeloplasty and other single-port urological robotic surgeries with the sp single-port robot; 2. patients who voluntarily decide to participate in the study and sign the icf (or exempt from signature of the icf as approved by the ec). exclusion criteria: the subjects meeting any of the following criteria should be excluded. 1. patients with missing data on the primary endpoint in retrospective cases; 2. subjects having any contraindications of single-port robot surgery; 3. the intraoperative anatomy determined that minimally invasive surgery was not suitable; 4. patients who are considered inappropriate to participate in this study by investigators.

Keywords: sp single-port robot radical prostatectomy partial nephrectomy radical nephrectomy radical resection of the renal pelvic carcinoma (one position) pyeloplasty and other single-port urological surgeries
midodrine hydrochloride in early sepsis

Conditions: Sepsis; Blood Pressure

Summary: the investigators would like to determine if early administration of oral midodrine in participants diagnosed with sepsis will impact blood pressures and decrease the need for and/or doses of intravenous pressor agents.

three doses of either placebo or midodrine every 8 hours will be administered in addition to usual care for sepsis. the goal will be to administer the first dose approximately within 24 hours of diagnosis. the first dose will be administered only after the patient has been admitted to the icu. subjects will receive treatment for a total of 16 hours starting from the first dose. the medical provider, nursing staff and patient will be blinded to randomization, only research pharmacist will be aware of randomization. blood pressure will be recorded at least on a 4 hourly basis for 24 hours from the time of administration of the first dose, and also just prior to administration of each dose. subsequent doses will be held if systolic blood pressure, sbp, is greater than 130 mmhg. if a subject requires initiation of intravenous vasopressor agents following study enrollment, subsequent doses will be continued. there will be no further intervention after all 3 doses have been administered; however clinical outcomes and adverse events will be monitored.

Eligibility criteria:
inclusion criteria: patients diagnosed with sepsis based on the old sepsis criteria and meeting all of the following criteria will be considered eligible to participate in the study. * age greater than or equal to 18 years * able to safely tolerate medication either by mouth or feeding tube (i.e. absence of nausea or vomiting) * able to give consent for participation or have representative available * two or more blood pressure readings taken at least 15 minutes apart with mean arterial pressures, maps 70 or less * treating consultant agrees to the study plan exclusion criteria: patients meeting any one of the following criteria will be excluded from participation: * women of child bearing age with the potential to become pregnant who do not have a clinically documented negative pregnancy test * current cardiogenic shock or known systolic heart failure with left ventricular ejection fraction (lvef) \< 30% * current bowel ischemia * recent myocardial infarction within the past 3 months * current use of monoamine oxidase inhibitors (maois) * recent stroke within the past 3 months * midodrine as a home medication * known allergy to midodrine * high dose vasopressor use (norepinephrine \>0.25 mcg/kg/min) * lactate more than 8 mmol/l * contraindications to use: history of pheochromocytoma or thyrotoxicosis or glaucoma or ischemic bowel disease
a phase 1, first-in-human study of the investigational covid-19 vaccine sc-ad6-1 in healthy volunteers

Conditions: Covid19

Summary: this is a single-centre, open-label, first-in-human, single ascending dose and multiple dose study to assess the safety, reactogenicity, and immunogenicity of the sc-ad6-1 investigational product when administered via the intramuscular (im), intranasal (in) or inhaled (ih) route in healthy volunteers.


Eligibility criteria:
key inclusion criteria: * adult males and females, 18 to 60 years of age (inclusive) * body mass index ≥ 18.0 and ≤ 32.0 kg/m2, with a body weight ≥ 50 kg at screening * must have been fully vaccinated against covid-19 and received last dose not less than 3 months prior to day 1 (high dose #3 i.m. and i.n. booster arms only), not less than 5 months prior to day 1 (high dose #4 i.n. booster arm only) and not less than 12 months prior to day 1 (i.h. booster arms and i.n or i.h. multiple dose booster arms only) key exclusion criteria: * history or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease * history of chronic respiratory disorders including asthma, emphysema, interstitial lung disease, pulmonary hypertension, recurrent pneumonia, or recent (≤14 days prior to screening) or ongoing respiratory tract infection * history of thrombosis (e.g., deep vein thrombosis, pulmonary embolism, etc.), any coagulation dysregulation disorder, or a history of thrombosis noted in immediate family members * history of any neurological disorders or seizures including guillain-barre syndrome, with the exception of febrile seizures during childhood * known previous infection with sars-cov-2 or presence of antibodies against sars-cov-2 or a positive sars-cov-2 pcr test (non-booster arms only) * any history of malignant disease ≤5 years prior to registration * history of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions such as common variable hypogammaglobulinemia
a study of androgen receptor (ar) antagonist apalutamide in chinese participants with metastatic castration-resistant prostate cancer

Conditions: Prostatic Neoplasms

Summary: the purpose of this study is to evaluate pharmacokinetics (pk) following a single dose and multiple dose treatment and the safety of apalutamide in chinese participants with metastatic castration resistant prostate cancer (mcrpc) at dose of 240 milligram (mg).


Eligibility criteria:
inclusion criteria: * eastern cooperative oncology group (ecog) performance status less than or equal to (\<=) 2 * histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features * metastatic disease as documented by bone scan or metastatic lesions by computed tomography or magnetic resonance imaging scans (visceral or lymph node disease). lymph nodes in the pelvis must measure at least 1.5 centimeter in a short axis to be considered target lesion according to the modified response evaluation criteria in solid tumors (recist) 1.1 based on the prostate cancer working group 2 (pcwg2) criteria * castration-resistant prostate cancer (pc) demonstrated during continuous androgen deprivation therapy (adt), defined as 3 rises of prostate-specific antigen (psa), at least 1 week apart, with the last psa greater than or equal to (\>=) 2 nanogram per milliliter (ng/ml) * prior hormonal interventions (including 1st generation antiandrogens \[flutamide, bicalutamide, nilutamide\], steroids, estrogens, finasteride, dutasteride) for pc are allowed. these therapies, except for gonadotropin releasing hormone analogs (gnrh) analogs and prednisone/prednisolone, must have been discontinued for minimally 4 weeks (2 weeks only for flutamide, nilutamide, or finasteride) before first dose of study drug exclusion criteria: * known brain metastases * chemotherapy, or immunotherapy within 2 weeks or 5 half-lives of the drug prior to the first dose of study drug, whichever is longer, with a maximum of 4 weeks. * prior treatment with second-generation anti-androgens (example \[eg\], enzalutamide) * administration of an investigational therapeutic within 2 weeks or 5 half-lives of the drug prior to the first dose of study drug, whichever is longer, with a maximum of 4 weeks. and participant use radiopharmaceutical agents (eg, strontium-89) or investigational immunotherapy (eg, sipuleucel-t) within 12 weeks prior to the first dose of study drug * prior treatment with cytochrome 17 inhibitors (eg, abiraterone acetate, orteronel, galeterone, systemic ketoconazole)
comparison study of non-invasive measurement of blood pressure and cardiac output during stress echocardiography

Conditions: High Cardiac Output; Low Cardiac Output

Summary: the objectives of the clinical trial is to validate hemodynamic parameters (blood pressure and cardiac output) generated by an application coupled with an off-the-shelf pulse oximeter. the validation will be done by comparing the generated information to data gathered while performing stress echocardiography. the first phase of the study will be done on 10 patients undergoing a stress echocardiography test at the cardiology department at meir hospital

the heartbeat system combines an fda/ce approved watch-like pulse oximeter for acquiring the data and an android software application that serves as the hemodynamic calculator. the application performs post-processing of the photoplethismographic (ppg) signal (normally the ppg signal in pulse oximeters is used only to compute heart rate and spo2). the raw data is transferred from the watch oximeter to the smartphone using a standard bluetooth protocol. the post-processing uses wavelet signal processing to estimate and display certain hemodynamic parameters like blood pressure (bp) and cardiac output (co) in a continuous and graphical way on a standard android device. in addition to the standard heart rate and spo2, the application displays the measured ppg signal and estimated continues bp and co. heartbeat is the only device that can non-invasively estimate continuous bp and its cardiac output component and the resistance component in a mobile wearable device. differentiating between these 2 components can play a major role in helping the doctor to understand the effect of cardiovascular medications and lifestyle interventions. the trial will compare blood pressure and cardiac output parameters measured during stress echocardiography using an echo cardiograph and standard sphygmomanometer to the parameters generated by the application. trial goals * feasibility tests for the heartbeat application as a tool for monitoring bp and co changes over time * compare bp and co parameters generated by the applications to the ones measured by standard non-invasive equipment during a stress echocardiography * calculate additional parameters such as stroke volume, systematic vascular resistance and cardiac index

Eligibility criteria:
inclusion criteria: * patients referred to an stress echocardiography test for cardiac diagnostics * male and female * between 18 to 90 years old exclusion criteria: * under the age of 18 or over 90 years old * patients in shock * patients with moderate or severe valvular disease * patients with severe sepsis * inadequate jurisprudence patients * patients supported by amines
a study to evaluate and compare the efficacy of two facial creams on moderately to severely photodamaged skin

Conditions: Photodamaged Skin

Summary: the objective of this study is to evaluate the efficacy of a retinol alternative-containing facial cream in improving skin texture, radiance/brightness, and the appearance of fine lines, wrinkles, uneven skin tone, and dark spots, with a positive control of a retinol-containing cream.


Eligibility criteria:
inclusion criteria: * fitzpatrick skin type i, ii, iii, or iv * final review of eligibility (visit 2): exhibits moderate to severe (score of 4-7 on a 0-9-point scale) overall photodamage on her face, as evaluated by the pi at visit 2 * final review of eligibility (visit 2): has a score of at least 4-7 (moderate to severe, on a 0-9-point scale) on at least 3 of the 5 following clinical grading parameters on her face, as evaluated by the pi at visit 2: i. global fine lines ii. wrinkles (under-eye and/or crow's feet) iii. tactile surface roughness iv. overall unevenness of skin tone v. lack of radiance/brightness vi. lack of skin firmness (look and/or feel) * generally in good health * able to read, write, speak, and understand english * individual has signed the consent for photograph release and icd including health insurance portability and accountability act disclosure * intends to complete the study and is willing and able to follow all study instructions exclusion criteria: * has known allergies or adverse reactions to common topical skincare products or ingredients in the investigational study materials * has a pre-existing or dormant facial dermatologic condition that, in the pi or designee's opinion, may confound the study results or otherwise be inappropriate for study participation (e.g., severe acne, acne conglobata, psoriasis, rosacea, rashes, eczema, atopic dermatitis, skin cancer, many and/or severe excoriations, observable suntan/sunburn, scars, nevi, tattoo, excessive hair, etc.) * has self-perceived very sensitive skin * has self-reported type 1 or type 2 diabetes or is taking insulin or another anti-diabetic medication. * is taking a medication/using a product that would mask an adverse event or confound the study results * is self-reported to be pregnant, lactating, or planning to become pregnant during the study or within 30 days of study completion * has a history of or a concurrent health/other condition/situation which, in the opinion of the pi, may put the individual at significant risk, confound the study results, or interfere significantly with the individual's participation in the study * has a surgery and/or invasive medical procedure planned during the study * is simultaneously participating in any other study or has participated in any study within 30 days prior to visit 1 * is an employee/contractor or immediate family member of the pi, study site, or sponsor
6 minute push & 30 second sprint tests reliability & relationship to fitness, participation, & environmental assessments

Conditions: Spinal Cord Injury

Summary: the purpose of this study is to assess the relationship between physical fitness and wheelchair mobility capacity and 1) participation; 2) self-reported environments barriers; and 3) self-reported avoidance of environmental features.


Eligibility criteria:
inclusion criteria: * at least 1 year post-injury * able to self-propel a manual wheelchair * spinal cord injury between c5 and t5 exclusion criteria: * spinal cord injury above c5 or below t5 * spinal cord injury severity of ais d * unstable angina or myocardial infarction within the past month * resting heart rate \>120 * systolic blood pressure \>180 mm hg, or diastolic blood pressure \>100 mm hg
evaluation of hepatic fibrosis on multiparametric mri

Conditions: Cirrhosis; Hepatitis

Summary: as cirrhosis progresses, alteration of hemodynamics develops and decreased portal flow is often observed. since direct measurement of portal pressure (hvpg) is invasive, non-invasive methods have drawn a lot of attention. mri is one of the non-invasive methods and it is able to provide multiparametric data in one examination. herein, we evaluate hepatic fibrosis with different stage using multiparametric mri with emphasis on portal flow measurement.


Eligibility criteria:
inclusion criteria: * chronic liver disease (viral hepatitis, alcoholic hepatitis, or other...) * or transplant recipient for viral hepatitis and on anti-viral agent medication * and scheduled for liver resection, biopsy or transient elastography * and signed informed consent exclusion criteria: * younger than 18 years * any contra-indication for contrast-enhanced mri * pregnant or nursing women * biliary obstruction * unable or unwilling to give informed consent

Keywords: liver fibrosis mri
nasal swab study to explore the nasal microbia

Conditions: Common Cold

Summary: the objective of this study is to evaluate the microbial consortia and the host inflammatory factors present in the nasal passages of patients during upper respiratory symptomology and when healthy using culture and molecular analysis techniques.


Eligibility criteria:
inclusion criteria: * adults, male or female, between the ages 18 - 60 * exhibiting symptoms of an upper respiratory ailment, which may include runny or stuffy nose, sore throat, fever, headache, cough, malaise, or loss of appetite with no indication or intention to treat with excluded medications. exclusion criteria: * use of antibiotics, antifungals, antivirals, antihistamines, anticholinergic, anti-inflammatory, any nasal inhaled medications (other than saline), or steroid medications within the four (4) weeks prior to enrollment and during the course of the study. use of cough suppressants and herbal medications are permitted.
the effect of chlorzoxazone on moderate to severe postoperative pain after spine surgery

Conditions: Chlorzoxazone; Postoperative Pain

Summary: chlorzoxazone is a centrally acting muscle relaxant used to treat muscle spasm and the resulting pain or discomfort. it acts on the spinal cord by depressing reflexes. our purpose is to investigate the effect of chlorzoxazone on moderate to severe postoperative pain after spine surgery. our hypothesis is that chlorzoxazone can reduce postoperative pain and reduce opioidconsumption and side effects compared to placebo.


Eligibility criteria:
inclusion criteria: * patients undergoing spine surgery in general anaesthesia. * postoperative pain \> 50 mm on the vas scale during mobilization. * patients who have not received analgesia 1 hour prior to inclusion. * asa 1-3. * bmi \> 18 og \< 40. * fertile women need a negative hcg urine test. * patients who have given their written consent to participate and understand the contents of the protocol. exclusion criteria: * participation in another clinical trial. * patients who do not speak and/or understand danish. * fertile women with a positive hcg urine test. * allergy to the drugs used in the trial. * alcohol or medicine abuse, assessed by investigator. * daily use of strong opioids (morphine, ketobemidone, oxynorm, methadone, fentanyl) * daily chlorzoxazone treatment. * known or suspected porphyria.

Keywords: chlorzoxazone postoperative pain spine surgery opioid consumption
"enhancing surgical safety in developing nations: investigating antibiotics' role in hand surgeries."

Conditions: Soft Tissue Injuries

Summary: the goal of this clinical trial is to compare the use of antibiotics with no use in people undergoing soft tissue hand surgery in developing countries. the main question it aims to answer is: • is an antibiotic necessary for this type of surgery in this population? researchers will compare a group of patients who receives antibiotics during the surgical procedure with a group who receives no antibiotics to see if infection rates are the same.


Eligibility criteria:
inclusion criteria: * individuals with clean soft tissue conditions of the upper limb requiring surgery exclusion criteria: * abandonment of treatment * asa \> 3

Keywords: antibiotic prophylaxis hand surgery orthopedic surgery postoperative care surgical wound infection developing country
vitamin d in systemic sclerosis patients with periodontitis

Conditions: Vitamin D Deficiency

Summary: vitamin d has been considered to possess anti-inflammatory and antimicrobial activity which may be a link for the known interaction of systemic sclerosis (ssc) and coronary heart disease (chd). this study investigated the association between serum vitamin d levels and ssc and periodontitis in patients with ssc, cp and with chd. furthermore, the objective was to determine if periodontitis and chd had an impact on serum vitamin d levels.

using a cross-sectional design, a total of 42 patients with ssc, 43 patients with chd, 41 patients with both ssc and cp, and 42 healthy patients were enrolled in the present study.

Eligibility criteria:
inclusion criteria: * presence of at least twenty teeth * cp with a minimum of 40% of sites with a clinical attachment level (cal) ≥2mm and probing depth (pd) ≥4mm; * presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs * presence of ≥40% sites with bleeding on probing (bop) exclusion criteria: * intake of contraceptives * intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study * status of pregnancy or lactation * previous history of excessive drinking * allergy to local anaesthetic * intake of drugs that may potentially determine gingival hyperplasia such as hydantoin, nifedipine, cyclosporin a or similar drugs.